MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TORFLEX TRANSSEPTAL GUIDING SHEATH; CATHETER, PERCUTANEOUS / DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	TF85-32-63-45
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the left atrial appendage closure (laac) procedure torflex transseptal guiding sheath was selected for use.It has been mentioned that during procedure the physician noticed the stopcock was broken and leaking.The procedure was completed successfully by using alternative device.No patient complications have been reported.The product is expected to be returned.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Correction to the initial mdr in block(s) h6.
Event or Problem Description
It was reported that during the left atrial appendage closure (laac) procedure torflex transseptal guiding sheath was selected for use.It has been mentioned that during procedure the physician noticed the stopcock was broken and leaking.The procedure was completed successfully by using alternative device.No patient complications have been reported.The product is expected to be returned.
Event or Problem Description
It was reported that during the left atrial appendage closure (laac) procedure torflex transseptal guiding sheath was selected for use.It has been mentioned that during procedure the physician noticed the stopcock was broken and leaking.The procedure was completed successfully by using alternative device.No patient complications have been reported.The product is expected to be returned.
Additional Manufacturer Narrative
Investigation summary: based on the available information, the root cause of the stopcock being broken and leaking of the sheath's stopcock was confirmed upon device return and inspection, it was observed that the stopcock break is confirmed via analysis done to the returned device.Device history record review: it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: upon device return and inspection, during the flushing test, the stopcock was found to leak at the lower end of the shaft; refer to the attachment.The issue is related to design.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.Investigation conclusion: the cause traced to device design cause code was selected specifically for the design of the primary packaging (die-cut card), based on the information provided within the event description.

• Brand Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Common Device Name: CATHETER, PERCUTANEOUS / DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; multitenant #2, street #58 zon; cartago, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23959467
• Report Number: 2124215-2026-00296
• Device Sequence Number: 5739987
• Product Code: DRE
• UDI-Device Identifier: 00685447005391
• UDI-Public: (01)00685447005391(17)280601(10)37598258
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K102948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TF85-32-63-45
• Device Catalogue Number: TF85-32-63-45
• Device Lot Number: 0037598258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 02/27/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/14/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown